FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEUROMETRICS MONITOR
K Number: K800452
·
Decision Apr 2, 1980
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
14
Applicant Total
3
Review Days
34
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Basic Information
- Device Name
- NEUROMETRICS MONITOR
- K Number
- K800452
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1420
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Neurometrics
- Date Received
- February 28, 1980
- Decision Date
- April 2, 1980
- Product Code
- GWS
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | FDA class 1 | Neurology |
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